Chlordiazepoxide and Amitriptyline Hydrochloride 14 mg/1
chlordiazepoxide and amitriptyline hydrochloride · TABLET, FILM COATED · Mylan Pharmaceuticals Inc.
This medication combines a benzodiazepine and a tricyclic antidepressant to treat anxiety and depression, particularly when both conditions occur together. It is taken by mouth as a coated tablet and requires a prescription from your doctor.
Key Facts
- Brand Name
- Chlordiazepoxide and Amitriptyline Hydrochloride
- Generic Name
- chlordiazepoxide and amitriptyline hydrochloride
- NDC Code (Product)
0378-0211- Manufacturer
- Mylan Pharmaceuticals Inc.
- Strength
- 14 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- ANDA071297
- Drug Class
- Benzodiazepine [EPC]
- Marketing Start
- 12/10/1986
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Chlordiazepoxide and amitriptyline hydrochloride tablets are indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety. The therapeutic response to chlordiazepoxide and amitriptyline hydrochloride tablets occurs earlier and with fewer treatment failures than when either amitriptyline or chlordiazepoxide is used alone. Symptoms likely to respond in the first week of treatment include: insomnia, feelings of guilt or worthlessness, agitation, psychic and somatic anxiety, suicidal ideation and anorexia.
Dosage & Administration
DOSAGE AND ADMINISTRATION Optimum dosage varies with the severity of the symptoms and the response of the individual patient. When a satisfactory response is obtained, dosage should be reduced to the smallest amount needed to maintain the remission. The larger portion of the total daily dose may be taken at bedtime. In some patients, a single dose at bedtime may be sufficient. In general, lower dosages are recommended for elderly patients. Chlordiazepoxide and amitriptyline hydrochloride tablets 10 mg/25 mg are recommended in an initial dosage of 3 or 4 tablets daily in divided doses; this may be increased to 6 tablets daily as required. Some patients respond to smaller doses and can be maintained on 2 tablets daily. Chlordiazepoxide and amitriptyline hydrochloride tablets 5 mg/12.5 mg in an initial dosage of 3 or 4 tablets daily in divided doses may be satisfactory in patients who do not tolerate higher doses. Screen for Bipolar Disorder Prior to Starting Chlordiazepoxide and Amitriptyline Hydrochloride Tablets Prior to initiating treatment with chlordiazepoxide and amitriptyline hydrochloride tablets or another antidepressant, screen patients for a personal or family history of b…
Warnings
WARNINGS Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including chlordiazepoxide and amitriptyline hydrochloride tablets, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe chlordiazepoxide and amitriptyline hydrochloride tablets concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. In patients already receiving an opioid analgesic, prescribe a lower initial dose of chlordiazepoxide and amitriptyline hydrochloride tablets than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking chlordiazepoxide and amitriptyline hydrochloride tablets, prescribe a l…
Contraindications
CONTRAINDICATIONS Chlordiazepoxide and amitriptyline hydrochloride tablets are contraindicated in patients with hypersensitivity to either benzodiazepines or tricyclic antidepressants. It should not be given concomitantly with a monoamine oxidase inhibitor. Hyperpyretic crises, severe convulsions and deaths have occurred in patients receiving a tricyclic antidepressant and a monoamine oxidase inhibitor simultaneously. When it is desired to replace a monoamine oxidase inhibitor with chlordiazepoxide and amitriptyline hydrochloride tablets, a minimum of 14 days should be allowed to elapse after the former is discontinued. Chlordiazepoxide and amitriptyline hydrochloride tablets should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. This drug is contraindicated during the acute recovery phase following myocardial infarction.
Adverse Reactions
ADVERSE REACTIONS Adverse reactions to chlordiazepoxide and amitriptyline hydrochloride are those associated with the use of either component alone. Most frequently reported were drowsiness, dry mouth, constipation, blurred vision, dizziness and bloating. Other side effects occurring less commonly included vivid dreams, impotence, tremor, confusion and nasal congestion. Many symptoms common to the depressive state, such as anorexia, fatigue, weakness, restlessness and lethargy, have been reported as side effects of treatment with both chlordiazepoxide and amitriptyline hydrochloride tablets and amitriptyline. Granulocytopenia, jaundice and hepatic dysfunction of uncertain etiology have also been observed rarely with chlordiazepoxide and amitriptyline hydrochloride tablets. When treatment with chlordiazepoxide and amitriptyline hydrochloride tablets is prolonged, periodic blood counts and liver function tests are advisable. Note Included in the listing which follows are adverse reactions which have not been reported with chlordiazepoxide and amitriptyline hydrochloride. However, they are included because they have been reported during therapy with one or both of the components or cl…
Frequently Asked Questions
What is Chlordiazepoxide and Amitriptyline Hydrochloride used for?
This medication combines a benzodiazepine and a tricyclic antidepressant to treat anxiety and depression, particularly when both conditions occur together. It is taken by mouth as a coated tablet and requires a prescription from your doctor.
Is Chlordiazepoxide and Amitriptyline Hydrochloride a controlled substance?
Yes, Chlordiazepoxide and Amitriptyline Hydrochloride is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for Chlordiazepoxide and Amitriptyline Hydrochloride?
The generic name for Chlordiazepoxide and Amitriptyline Hydrochloride is chlordiazepoxide and amitriptyline hydrochloride. There are no other listed brand versions of chlordiazepoxide and amitriptyline hydrochloride.
What is the NDC code for Chlordiazepoxide and Amitriptyline Hydrochloride 14 mg/1?
The NDC (National Drug Code) for Chlordiazepoxide and Amitriptyline Hydrochloride 14 mg/1 is 0378-0211, listed by Mylan Pharmaceuticals Inc..
Other Chlordiazepoxide and Amitriptyline Hydrochloride Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)